FDA Approves Caris Life Sciences' MI Cancer Seek as Companion Diagnostic
Key Insights
The FDA has approved Caris Life Sciences (search)' MI Cancer Seek (search), a comprehensive genomic profiling assay, as a companion diagnostic to identify cancer (search) patients who may benefit from targeted therapies.
MI Cancer Seek (search) utilizes simultaneous whole-exome and whole-transcriptome sequencing to analyze solid tumors (search), providing a comprehensive molecular blueprint in a single workflow.
The assay includes one pan-cancer (search) and five tumor-specific indications for numerous FDA-approved therapies and is available for use in patients aged 1 to 22.
The U.S. Food and Drug Administration (FDA) has granted approval to Caris Life Sciences (search)' MI Cancer Seek (search), a novel assay designed as a companion diagnostic to pinpoint cancer (search) patients who could benefit from targeted therapies. This approval marks a significant advancement in precision medicine, offering a comprehensive approach to molecular profiling of solid tumors (search).
MI Cancer Seek (search) integrates whole-exome sequencing and whole-transcriptome sequencing into a single workflow. This approach allows for the detection of single nucleotide variants, insertions, deletions, microsatellite instability, tumor mutational burden, and copy number amplifications. The assay analyzes total nucleic acid isolated from formalin-fixed paraffin-embedded tumor tissue specimens.
Comprehensive Genomic Profiling
Traditionally, DNA and RNA analyses via next-generation sequencing require separate testing processes, demanding more tissue and time. MI Cancer Seek (search) streamlines this process by combining whole-exome sequencing and whole-transcriptome sequencing, conserving tissue while maintaining thorough results. The assay includes one pan-cancer (search) and five tumor-specific indications for numerous FDA-approved therapies and is available for use in patients aged 1 to 22.
Intended Use and Benefits
MI Cancer Seek (search) is designed to identify patients who may benefit from targeted therapies, as indicated in the Companion Diagnostic Indications table, aligning with approved therapeutic product labeling. Additionally, it provides tumor mutational profiling for use by qualified healthcare professionals, following professional oncology guidelines for patients with previously diagnosed solid malignancies. It's important to note that genomic findings beyond those listed in the Companion Diagnostic Indications table are not prescriptive or conclusive for labeled use of any specific therapeutic product.
Leadership Perspective
"FDA approval of MI Cancer Seek (search) further demonstrates Caris' continued leadership in molecular science and our extreme focus on quality," said David Dean Halbert, DSc (hc), Chairman, founder, and Chief Executive Officer of Caris Life Sciences (search). "We are thrilled to bring MI Cancer Seek to market to ensure patients have access to critical precision medicine tools."
David Spetzler, MS, PhD, MBA, President of Caris Life Sciences (search), added, "We are very excited to receive FDA approval for our MI Cancer Seek (search) test. The extensive rigor with which the FDA evaluates new technology ensures patients have access to safe and effective tests. The process of working with the FDA was both collaborative and insightful, and we applaud their expertise in the evaluation of novel technologies."